CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements

USFDA Guidelines for Pharmaceuticals
ELECTRONIC RECORDS AND SIGNATURES
IN PHARMACEUTICALS.
The presentation discusses details of 21 CFR Part 11 requirements and guidance for industry for the same.
Details of Part 11 requirements for Electronic Records, Electronic Signatures, Validation of Computerized System, Audit trail, Handwritten signatures has been explained.
Discretion of legacy system along with requirements for validation, retention has been defined.
CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements.